ICH Quality Guidelines PDF Download
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Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1118971124
Category : Medical
Languages : en
Pages : 737
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Book Description
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1118971124
Category : Medical
Languages : en
Pages : 737
Get Book Here
Book Description
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 0470934751
Category : Medical
Languages : en
Pages : 455
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Book Description
This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.
Author: Q. Alan Xu
Publisher: John Wiley & Sons
ISBN: 1118533984
Category : Technology & Engineering
Languages : en
Pages : 342
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Book Description
Explores both the benefits and limitations of new UHPLC technology High performance liquid chromatography (HPLC) has been widely used in analytical chemistry and biochemistry to separate, identify, and quantify compounds for decades. The science of liquid chromatography, however, was revolutionized a few years ago with the advent of ultra-high performance liquid chromatography (UHPLC), which made it possible for researchers to analyze sample compounds with greater speed, resolution, and sensitivity. Ultra-High Performance Liquid Chromatography and Its Applications enables readers to maximize the performance of UHPLC as well as develop UHPLC methods tailored to their particular research needs. Readers familiar with HPLC methods will learn how to transfer these methods to a UHPLC platform and vice versa. In addition, the book explores a variety of UHPLC applications designed to support research in such fields as pharmaceuticals, food safety, clinical medicine, and environmental science. The book begins with discussions of UHPLC method development and method transfer between HPLC and UHPLC platforms. It then examines practical aspects of UHPLC. Next, the book covers: Coupling UHPLC with mass spectrometry Potential of shell particles in fast liquid chromatography Determination of abused drugs in human biological matrices Analyses of isoflavones and flavonoids Therapeutic protein characterization Analysis of illicit drugs The final chapter of the book explores the use of UHPLC in drug metabolism and pharmacokinetics studies for traditional Chinese medicine. With its frank discussions of UHPLC's benefits and limitations, Ultra-High Performance Liquid Chromatography and Its Applications equips analytical scientists with the skills and knowledge needed to take full advantage of this new separation technology.
Author:
Publisher: Academic Press
ISBN: 0128144246
Category : Medical
Languages : en
Pages : 881
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Book Description
Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Author: Shelley Chambers Fox
Publisher: Pharmaceutical Press
ISBN: 0857110705
Category : Medical
Languages : en
Pages : 561
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Book Description
Remington Education: Pharmaceutics covers the basic principles of pharmaceutics, from dosage forms to drug delivery and targeting. It addresses all the principles covered in an introductory pharmacy course. As well as offering a summary of key information in pharmaceutics, it offers numerous case studies and MCQs for self assessment.
Author: Xiaodong Liu
Publisher: Springer Nature
ISBN: 9811376476
Category : Medical
Languages : en
Pages : 588
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Book Description
This book provides with a comprehensive overview of the role of drug transporters in drug disposition and efficacy/toxicity, as well as drug-drug interactions and recent advances in the field. Transporters are known determinants of drug disposition and efficacy/toxicity. In general, they are divided into solute carrier (SLC) and ATP binding cassette (ABC) families, and are located along cell membranes, where they mediate drug uptake into cells and export out of cells. Drug transporters are essential in maintaining cell homeostasis, and their gene mutations may cause or contribute to severe human genetic disorders, such as cystic fibrosis, neurological disease, retinal degeneration, anemia, and cholesterol and bile transport defects. Conversely, some diseases may also alter transporter functions and expressions, in turn aggravating disease process. Further, since over-expression of some ABC transporters is a potential contributor to multidrug-resistance (MDR), the book presents a number of strategies to overcome MDR, including ABC transporter inhibitors and applying epigenetic methods to modulate transporter expressions and functions. This book is useful for graduate students and professionals who are looking to refresh or expand their knowledge of this exciting field.
Author: Hong Wen
Publisher: John Wiley & Sons
ISBN: 1118060326
Category : Science
Languages : en
Pages : 571
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Book Description
This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.
Author: James E. Barrett
Publisher: Springer Nature
ISBN: 3030353621
Category : Medical
Languages : en
Pages : 457
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Book Description
Celebrating 100 years of HEP, this volume will discuss key pharmacological discoveries and concepts of the past 100 years. These discoveries have dramatically changed the medical treatment paradigms of many diseases and these concepts have and will continue to shape discovery of new medicinies. Newly evolving technologies will similarly be discussed as they will shape the future of the pharmacology and, accordingly, medical therapy.
Author: Ronald P. Evens
Publisher: Springer Science & Business Media
ISBN: 0387329781
Category : Medical
Languages : en
Pages : 394
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Book Description
This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.
Author: Yuichi Sugiyama
Publisher: Springer Science & Business Media
ISBN: 1461482291
Category : Medical
Languages : en
Pages : 322
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Book Description
Transporters in Drug Development examines how membrane transporters can be dealt with in academic–industrial drug discovery and pharmaceutical development as well as from a regulatory perspective. The book describes methods and examples of in vitro characterization of single transporters in the intestines, liver and kidneys as well as characterization of substrate overlap between various transporters. Furthermore, probes and biomarkers are suggested for studies of the transporters’ impact on the pharmacokinetics of drug substrates/candidates interacting on transporters. The challenges of translating in vitro observed interaction of transporters into in vivo relevance are explored, and the book highlights perspectives of applying targeted proteomics and mechanistic modeling in this process.
